Colchicine: First-Line Therapy in Pericarditis?

Action Points

Note that this large randomized trial suggests that the use of colchicine as a first-line agent for acute pericarditis appears to be safe and effective.

Be aware that the study was conducted in Italian centers which may limit generalizability to broader populations.

Indications for the anti-inflammatory drug colchicine could be expanded to include treatment of acute pericarditis and subsequent recurrence, a randomized trial suggested.

Only 16.7% of patients randomized to colchicine had incessant or recurrent pericarditis compared with 37.5% of those receiving placebo along with standard care, according to Massimo Imazio, MD, of Vittoria Hospital in Turin, Italy, and colleagues.

Those receiving colchicine had a relative risk reduction of 44%, translating into a number needed to treat of four, they wrote in the study published online in the New England Journal of Medicine to coincide with presentation at the European Society of Cardiology meeting in Amsterdam.

"This is certainly good news, but we have to remember that colchicine is not a benign drug," Mariell Jessup, MD, from the University of Pennsylvania, told MedPage Today.

"It is cleared by the kidneys; so in patients with renal failure, it can cause toxicity," she said.

It is only more recently that it has been used for this purpose. In a previous study called Colchicine for Acute Pericarditis, Imazio and colleagues found the drug reduced recurrent pericarditis by 50%.

A total of 240 patients were enrolled from five general hospitals in Northern Italy from August 2005 to December 2010. The first attack of pericarditis could be idiopathic (77% of patients), viral (0%), after cardiac injury (20%), or associated with connective-tissue disease (3%).

Patients were randomized in a 1:1 ratio to receive colchicine (0.5 to 1.0 mg daily for 3 months) or placebo. Lower-weight patients and those showing side effects received the lower dose of the study drug.

The standard care for pericarditis delivered along with the study drug or placebo comprised either 800 mg of aspirin or 600 mg of ibuprofen every 8 hours for 7 to 10 days, then tapered down over 3 to 4 weeks. Kaplan-Meier curves showed no difference in freedom from incessant or recurrent pericarditis for patients in the colchicine arm whether they were taking aspirin or ibuprofen.

Those contraindicated to aspirin or ibuprofen received glucocorticoid therapy (5% in the study arm, 8% in the placebo arm). In multivariate analysis, the use of glucocorticoids was an independent risk factors for recurrence, as was elevated C-reactive protein.

Researchers followed each patient for at least 18 months, with regular visits at planned intervals. The mean age was 52 and almost two-thirds were men.

Those in the colchicine group had a 9.2% recurrence rate compared with 20.8% in the placebo group, translating into a number needed to treat of nine for preventing recurrence.

Regarding secondary endpoints, colchicine reduced the frequency of symptom persistence at 72 hours (19% versus 40%), number of recurrences per patient (0.21 versus 0.52), and the rate of hospitalizations related to pericarditis (5% versus 14%). All differences were significant.

The study drug also prolonged the time to first recurrence (24 versus 17 weeks).

The results may not be applicable to other patient populations, women who are pregnant or lactating, or to children, the authors cautioned. Also, the relatively small number of patients may have prevented the identification of rare adverse effects, Finally, the treatment duration of 3 months was chosen arbitrarily and longer treatment time "might further decrease the 9% to 10% recurrence rate."

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